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Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis

NCT00625326 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2011-04-27

No results posted yet for this study

Summary

Low doses of topically administered vitamin D analogs have been shown to have an anti-psoriatic effect without the risk of hypercalcemia. Calcipotriol, the most thoroughly studied of the vitamin D analogs, was first approved in Europe in the early 1990s. It has been shown to be comparable or slightly more effective than class II corticosteroid ointments. However, patients had reduced levels of parathyroid hormone; mean serum and urine calcium were increased during treatment and hypercalciuria was observed. These effects were reversible with discontinuation of therapy. Thus, while calcipotriol ointment was shown to be effective, the potential for alterations in calcium homeostasis have limited its use to 100 g of ointment per week (0.5 mg calcipotriol/week). Work has continued on the creation of new vitamin D analogs, such as COL-121, with the intent of eliminating the adverse effects of hypercalcemia and hypercalciuria with a compound that is more stable and more easily administered.

Conditions

  • Plaque-type Psoriasis

Interventions

DRUG

COL-121

75 µg/g COL-121 Ointment

DRUG

50 µg/g Calcipotriene Ointment

50 µg/g Calcipotriene Ointment

DRUG

Placebo

Placebo

DRUG

COL-121

150 µg/g COL-121 Ointment

DRUG

COL-121

300 µg/g COL-121 Ointment

Sponsors & Collaborators

  • Deltanoid Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Michael Graeber, MD · Galderma R&D

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-12-31
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00625326 on ClinicalTrials.gov